Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App

August 4, 2026 updated by: Mayo Clinic

Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)

This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.

OUTLINE: This is an observational study.

Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Renee Bradshaw
  • Phone Number: 507-284-2511

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Svetomir N. Markovic, MD, PhD
        • Contact:
          • Renee Bradshaw
          • Phone Number: 507-284-2511
        • Principal Investigator:
          • Lisa A. Kottschade, APRN, CNP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with the diagnosis of skin cancer/melanoma undergoing dual ICI therapy with ipilimumab/nivolumab (IPI/Nivo) as part of regular clinical practice.

Description

Inclusion Criteria:

  • Any skin cancer/melanoma patient starting dual [ipilimumab/nivolumab (IPI/NIVO)] immune checkpoint inhibitor (ICI) therapy

Exclusion Criteria:

  • Does not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.
Other: Non-Interventional Study
Non-Interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3-4 IR-adverse events
Time Frame: Up to 100 days following treatment with IPI/NIVO
Will be assessed by the number of patients who experience at least one grade 3-4 Immune-Related Adverse Events (IR-AE) within 100 days of treatment with ipilimumab/nivolumab (IPI/NIVO). Events will be self-reported using the VIGILANT app, which is being developed to help manage adverse events after treatment.
Up to 100 days following treatment with IPI/NIVO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Svetomir N. Markovic, MD, PhD, Mayo Clinic
  • Principal Investigator: Lisa A. Kottschade, APRN, CNP, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-011475 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2024-09081 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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